Boston Scientific Corporation recalls PROPONENT DR Pacemaker
Reason for recall
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
Lot / code information
- UDI
- 00802526559044, 00802526578014, 00802526576379, 00802526576874
- Serial #
760500 100707 100788 100793 100800 100803 100804 100808 100838 100839 713123 714640 714796 715611 715757 715779 715795 715799 715802 715805 715831 715842 715847 715854 715886 715905 715907 715912 7159…Show all
760500 100707 100788 100793 100800 100803 100804 100808 100838 100839 713123 714640 714796 715611 715757 715779 715795 715799 715802 715805 715831 715842 715847 715854 715886 715905 715907 715912 715934 715949 715953 715981 715986 715991 715993 716002 716005 716007 716011 716016 716028 716044 716045 716054 716063 716066 716081 716097 716106 716147 716148 716162 716163 716171 716182 716183 716190 716194 716205 716208 716228 716237 716239 716247 716250 716255 716256 716260 716267 716282 716288 716289 716290 716291 716292 716306 716309 716315 716317 716333 716342 716346 716360 716375 716380 716396 716407 716410 716419 716421 716423 716424 716426 716433 716435 716443 716455 716473 716514 716543 716545 716572 716605 716610 716629 716641 716680 716715 716721 716727 716750 716759 716760 716769 716779 716803 716836 716839 716841 716845 716868 716990 716994 716997 717000 717009 717018 717034 717040 717053 717070 717083 717098 717099 717108 717118 717124 717153 717156 717166 717182 717189 717197 717248 717250 717274 717302 717306 717310 717313 717314 717369 717378 717413 717491 717525 717533 717570 717577 717583 717593 717600 717700 717816 717877 717878 717885 717896 717906 717917 717931 717963 717978 717991 717994 717996 718005 718021 718137 718242 718418 718492 718494 718504 718528 718552 718558 718600 718601 718605 718608 718617 718627 718630 718631 718640 718659 718667 718668 718672 718675 718676 718680 718683 718697 718705 718711 718713 718716 718733 718743 718747 718748 718762 718775 718778 718784 718794 718801 718805 718806 718807 718820 718831 718833 718852 718860 718868 718881 718882 718883 718890 718892 718893 718894 718896 718900 718901 718908 718914 718915 718931 718972 718979 718989 718990 719003 719014 719016 719045 719948 723990 724576 724581 724583 724597 724612 724614 724616 724619 724620 724640 724644 724645 724654 724658 724663 724664 724665 724666 724670 724671 724678 724683 724698 724700 724701 724703 724724 724731 724732 724733 724747 724752 724753 724756 724765 724766 724768 724770 724773 724774 724781 724783 724785 724786 724797 724807 724809 724810 724811 724812 724813 724814 724815 724816 724817 724818 724820 724823 724826 724829 724833 724869 724950 724958 724974 724975 724977 724980 724981 725651 725734 725742 725774 725775 725787 725894 725949 726012 726021 726027 726030 726077 726083 726115 726129 726160 726176 726178 726202 726385 726393 726425 726436 726489 726496 726546 726552 726563 726596 726600 726728 726733 726736 726790 726791 726806 726822 732778 732914 732938 732999 733010 733301 733409 733459 734188 735202 735235 735930 736403 736415 736577 737251 737265 737295 737344 737419 737481 737513 737625 737659 737926 737953 737979 737997 737999 738014 738195 738250 738328 738332 738356 738449 738466 738516 738617 738684 738690 738691 738692 738721 738724 738745 738746 738764 738794 738825 738834 738836 738839 739420 739422 739854 739903 739927 739936 739980 740026 740099 740178 740206 740375 741218 741219 741222 741234 741241 741242 741287 741396 741404 741663 741696 741730 741837 741970 742029 742031 742033 742045 742079 742107 742141 742206 742209 742215 742216 742235 742256 742265 742267 742270 742274 742295 742297 742324 742331 742333 742337 742359 742372 742402 742435 742436 742443 742444 742451 742461 742475 742491 742514 742520 742532 742536 742548 742556 742566 742588 742606 742607 742613 742614 742618 742620 742621 742625 742640 742667 742677 742746 742748 742754 742815 742849 742858 742866 742878 742885 742931 742932 742960 742985 743012 743064 743073 743086 743093 743102 743106 743107 743137 743141 743187 743205 743229 743253 743328 743343 743353 743362 743372 743383 743384 743397 743454 743456 743460 743461 743462 743477 743535 743858 743983 743985 743988 743989 744006 744018 744019 744020 744022 744028 744029 744030 744033 744037 744040 744046 744048 744049 744050 744051 744052 744053 744054 744068 744070 744071 744072 744073 744076 744078 744079 744081 744083 744087 744090 745089 745110 745215 745469 745477 745618 745638 745674 745695 745704 745729 745733 745734 745736 745739 745740 745741 745752 745754 745756 745761 745764 745768 745770 745782 745786 745791 745792 745799 745805 745809 745827 745833 745834 745845 745851 745853 745858 745859 745869 745875 745878 745881 745882 745883 745885 745887 745888 745889 745896 745901 745903 745904 745906 745907 745909 745910 745911 745913 745914 745915 745916 745918 745919 745921 745922 745923 745934 745935 745936 745937 745940 745942 745945 745946 745947 745948 745949 745950 745954 745956 745959 745960 745962 745964 745965 745966 745971 745972 745973 745974 745975 745976 745977 745978 745979 745980 745985 745987 745990 745995 745999 746001 746002 746003 746005 746007 746008 746010 746011 746013 746018 746021 746023 746025 746026 746027 746028 746030 746033 746034 746035 746036 746041 746042 746043 746044 746046 746047 746049 746050 746051 746052 746056 746058 746059 746061 746062 746064 746065 746066 746067 746068 746069 746072 746073 746074 746076 746077 746078 746079 746081 746082 746083 746085 746086 746087 746088 746089 746090 746092 746093 746094 746095 746096 746097 746098 746100 746101 746102 746103 746107 746114 746115 746116 746117 746118 746119 746120 746121 746122 746123 746124 746125 746126 746130 746131 746136 746144 746145 746152 746189 746248 746257 746285 746293 746308 746320 746322 746341 746346 746368 746374 746376 746389 746443 746451 746453 750039 750690 750814 750893 751125 751479 751497 751524 751532 751586 751587 751589 751591 751612 751616 752076 752078 752079 752080 752105 752166 752180 752229 752234 752236 752261 752274 752296 752297 752312 752349 752406 752407 752409 752585 752607 752660 752661 752676 752894 752929 753368 753857 754853 754863 754866 754876 754878 754882 754884 754939 754946 754961 760408 760539 760542 760544 760548 760549 760553 760832 760860 760870 760881 760939 761502 761519 761570 761632 763231 763232 763347 763356 763585 763704 763711 763987 764009 764040 764047 7 …- UDI
- 00802526559068, 00802526576386
- Serial #
100161 700001 700002 700003 700004 700005 700006 700007 700008 700009 700010 700011 700012 700013 700014 700015 700016 700017 700018 700019 700020 700021 700022 700023 700024 700025 700026 700027 7000…Show all
100161 700001 700002 700003 700004 700005 700006 700007 700008 700009 700010 700011 700012 700013 700014 700015 700016 700017 700018 700019 700020 700021 700022 700023 700024 700025 700026 700027 700028 700029 700030 700031 700032 700033 700034 700035 700037 700038 700039 700040 700041 700042 700043 700044 700046 700047 700048 700050 700051 700053 700054 700055 700056 700057 700058 700059 700060 700061 700062 700063 700064 700065 700066 700067 700068 700069 700070 700071 700072 700073 700074 700075 700076 700078 700079 700080 700081 700082 700083 700084 700085 700086 700087 700088 700090 700091 700092 700093 700094 700095 700096 700097 700098 700099 700100 700101 700102 700103 700104 700105 700106 700107 700108 700109 700110 700111 700112 700113 700115 700116 700117 700118 700119 700121 700122 700123 700124 700125 700126 700127 700128 700129 700130 700131 700132 700133 700134 700135 700136 700147 700148 700149 700150 700151 700152 700153 700154 700155 700156 700157 700158 700167 700168 700175 700176 700177 700178 700179 700180 700181 700182 700183 700184 700185 700186 700225 700226 700227 700242 700243 700244 700245 700252 700253 700254 700255 700256 700257 700258 700260 700261 700262 700263 700276 700278 700279 700280 700281 700282 700283 700284 700293 700294 700295 700296 700297 700298 700299 700300 700301 700302 700303 700304 700319 700321 700323 700325 700326 700327 700328 700329 700330 700331 700332 700333 700334 700336 700337 700338 700339 700340 700341 700342 700343 700345 700346 700347 700348 700349 700350 700351 700352 700353 700354 700355 700356 700357 700358 700359 700366 700367 700368 700369 700371 700372 700373 700374 700375 700376 700378 700379 700380 700381 700382 700383 700385 700387 700388 700389 700390 700401 700402 700403 700404 700405 700406 700407 700411 700412 700413 700414 700415 700425 700426 700427 700429 700430 700431 700432 700433 700441 700442 700443 700445 700446 700447 700448 700449 700450 700451 700452 700453 700461 700462 700463 700464 700465 700466 700467 700488 700490 700508 700509 700511 700513 700515 700516 700517 700518 700519 700521 700522 700523 700524 700525 700526 700527 700528 700529 700531 700532 700533 700535 700536 700537 700538 700539 700540 700541 700543 700544 700545 700546 700547 700548 700549 700550 700551 700552 700553 700554 700555 700556 700557 700558 700559 700560 700565 700574 700575 700576 700577 700578 700579 700580 700581 700582 700583 700584 700585 700592 700593 700594 700595 700610 700611 700612 700613 700614 700615 700616 700617 700618 700619 700620 700621 700622 700623 700624 700625 700626 700627 700628 700658 700659 700660 700661 700662 700663 700664 700665 700666 700667 700668 700669 700670 700671 700672 700673 700674 700675 700676 700677 700678 700688 700689 700690 700691 700692 700693 700694 700695 700696 700697 700698 700704 700705 700706 700707 700708 700709 700710 700713 700714 700715 700716 700717 700718 700722 700723 700725 700726 700727 700728 700729 700730 700731 700732 700733 700734 700735 700736 700737 700738 700739 700740 700741 700756 700757 700758 700759 700760 700761 700762 700763 700768 700770 700771 700772 700773 700784 700785 700786 700787 700788 700789 700790 700791 700792 700793 700794 700802 700804 700806 700807 700808 700809 700811 700821 700822 700823 700824 700825 700826 700827 700828 700829 700830 700831 700832 700839 700851 700853 700854 700855 700856 700875 700876 700882 700883 700884 700886 700887 700889 700890 700892 700926 700949 700950 700952 700954 700955 700956 700957 700958 700959 700960 700961 700962 700963 700964 700965 700967 700969 700970 700971 700972 700973 700974 700975 700976 700978 700979 700980 700981 700982 700983 700984 700989 700991 700992 700993 700994 700995 700996 700997 700998 700999 701000 701001 701002 701003 701154 701155 701158 701159 701160 701161 701162 701163 701196 701197 701198 701202 701203; L211 -- UDI
- 00802526578038, 00802526559105, 00802526576409, 00802526576904
- Serial #
251896 100885 101747 101748 101796 101797 101800 101813 101815 101817 101819 101826 101831 101832 101834 101836 101837 101845 101849 101852 101854 101855 101857 101858 101861 101870 101871 101872 1018…Show all
251896 100885 101747 101748 101796 101797 101800 101813 101815 101817 101819 101826 101831 101832 101834 101836 101837 101845 101849 101852 101854 101855 101857 101858 101861 101870 101871 101872 101873 101886 101892 101905 101906 101909 101914 101915 101916 101921 101930 101941 101958 101962 101974 101991 101998 102020 102028 102029 102030 102033 102036 102038 102041 102054 102055 102056 102063 102069 102099 102100 102103 102104 102105 102119 102123 102124 102148 102152 102153 102163 102165 102187 102199 102200 102202 102203 102204 102205 102207 102209 102212 102215 102220 102227 102228 102231 102233 102236 102238 102251 102263 102264 102266 102268 102273 102285 102296 102300 102302 102306 102310 102314 102315 102316 102317 102318 102327 102329 102333 102334 102341 102344 102346 102348 102353 102354 102355 102366 102368 102369 102373 102374 102375 102376 102380 102381 102383 102386 102389 102392 102397 102403 102407 102409 102411 102415 102421 102422 102425 102428 102429 102430 102440 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Additional code information
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What the firm is doing
The firm sent an "URGENT MEDICAL DEVICE INFORMATION" letter dated December 2024. The letter describes the product, problem and actions to be taken. The customers were instructed to promptly identify patients, if device enters Safety Mode, perform emergent replacement for patients who are at risk for harm, during replacement of a device in Safety Mode pacing inhibition should be anticipated during electrocautery. General prophylactic replacement is not recommended; schedule device replacement promptly when the longevity remaining reaches four (4) years or if the longevity remaining is less than 4 years, perform system follow-ups in accordance with the instructions for use and update patients records with letter to maintain awareness for the remaining service life of the device. If you have any questions regarding this information or would like to report a clinical event, contact your Boston Scientific representative or Technical Services. Supplement March 26, 2025, High-Level Overview of Recall Strategy: on 03/26/2025, BSC notified only those implanting and following clinicians responsible for the newly identified active advisory devices. The letter sent to these clinicians will be the original December 12, 2024, Product Advisory letter, however, the March 2025 communication included a cover letter stating that new devices were identified that should have been initially categorized in the Advisory population.
DistributionShow detailsHide
US (Nationwide) including Puerto Rico and US Virgin Islands and OUS (foreign) to countries of: Guam and Northern Mariana Islands.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0823-2025
- FDA device classification · LWPOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Boston Scientific CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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